Company Expects to Complete Submission for Fast Track Designated Medicine by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Aug. 21, 2017– Alkermes plc (NASDAQ:ALKS) today announced the initiation of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a […]

BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia NEW YORK – August 17, 2017 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed […]

NEW YORK, August 3, 2017 – Pfizer Inc. announced today that the United States Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis (PsA). Pfizer submitted supplemental new drug applications (sNDAs) for […]

Collaboration Aims to Maximize the Potential of PARP and MEK Inhibitors in Combination with PD-L1/PD-1 Medicines, Based on Growing Scientific Evidence That These Combinations Offer New Potential for the Treatment of a Range of Tumor Types AstraZeneca and Merck Will Independently Develop and Commercialize LYNPARZA and Potential Medicine Selumetinib in Combinations with Companies’ Respective PD-L1/PD-1 […]

Designed to Assess Weight Gain Profile of Olanzapine Compared to ALKS 3831 in Patients Diagnosed With Schizophrenia, Schizophreniform or Bipolar I Disorder Who Are Early in Their Illness Supportive Study in the ENLIGHTEN Clinical Development Program for ALKS 3831, an Investigational, Novel, Once-Daily, Oral Atypical Antipsychotic for the Treatment of Schizophrenia DUBLIN–(BUSINESS WIRE)–Jun. 8, 2017– […]

Dr. Susan Emmett will make a presentation in Tanzania about reducing hearing health disparities across the globe DURHAM, N.C. May 23, 2017 – Otolaryngologist Susan Emmett, M.D., an assistant professor of surgery at Duke University School of Medicine and assistant research professor at the Duke Global Health Institute, has been selected as a TED Fellow. […]